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ESC 2017: Renal Denervation Lowers Blood Pressure in
Hypertensive Patients Not Taking AntihypertensiveMedication
– SPYRAL HTN-OFFMED Trial
Renal denervation has been shown to lower blood pressure in hypertensive patients not taking antihypertensive
medication. This outcome of the international, multicenter, prospective, randomized, sham-controlled SPYRAL HTN-OFF
MED trial was reported at the 2017 European Society of Cardiology (ESC) Congress, from August 26–30.
M
ichael Boehm, MD, PhD, of the
University of Saarland, Homburg/
Saar, Germany, explained that
renal denervation is a minimally invasive
catheter-based procedure that delivers
energy to the nerves in the kidneys. It was
developed to treat resistant hypertension.
Coinvestigator David Kandzari, MD, of the
Piedmont Heart Institute, Atlanta, Georgia,
said, “After SYMPLICITY HTN-3, we learned
a lot about the procedure itself, medication
adherence, and which patients may have
less response to the renal denervation
procedure – these insights have been
incorporated into the revised clinical
approach in the SPYRAL HTN program.”
He continued, “With this new approach
and protocol design, coupled with new
technology that allows more consistent
circumferential treatment and easier access
into the distal anatomy, based on these
compelling results we are confident that
we’ve addressed the issues of previous
renal denervation trials appropriately.”
SPYRAL HTN-OFF MED was designed to
evaluate the safety and blood pressure-
lowering efficacy of the multi-electrode
Symplicity Spyral renal denervation
system. The study included patients with
uncontrolled hypertension who were drug-
naïve or stopped taking antihypertensive
medications at least 4 weeks prior to
randomization.
Uncontrolled hypertension was defined
as an office systolic blood pressure 150–
180 mmHg and diastolic blood pressure
>90 mmHg, and a 24-h mean systolic
blood pressure 140–170 mmHg.
Patients were randomized to renal
denervation in the main renal arteries and
branches or to a sham procedure. Blood
pressure was measured at baseline and
3 months, and compared within each
treatment group.
Dr. Boehm presented 3-month results of the
first 80 patients, 38 of whom received renal
denervation and 42 the sham procedure.
Compared to baseline, at 3 months after
the procedure, office-based systolic and
diastolic blood pressure had declined
by 10.0 mmHg (P < .001) and 5.3 mmHg
(P = .008) in the renal denervation arm,
respectively, vs declines of 2.3 and
0.3 mmHg (neither significant) in the sham
arm, respectively.
Regarding 24-h ambulatory blood pressure
vs baseline, systolic and diastolic blood
pressure of patients undergoing renal
denervation decreased by 5.5 mmHg (P =
.04) and 4.8mmHg (P < .001), respectively. In
the sham control arm, systolic and diastolic
blood pressure decreased by 0.5 and
0.4 mmHg, respectively (neither significant).
Decreases in systolic and diastolic office
and 24-h blood pressure were confirmed
by directly comparing between the renal
denervation and sham groups.
No major safety events were reported
in either arm, even with the revised
procedural approach. The latter increased
the total number of ablations and included
denervation in the branch arteries.
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18
PRACTICEUPDATE CARDIOLOGY